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Kyverna Therapeutics Receives U.S. FDA RMAT Designation for KYV-101 in the Treatment of Patients With Progressive Myasthenia Gravis
The application was evaluated based on the positive clinical outcomes in patients treated in Germany under the named-patient program The Regenerative Medicine
About this update from Kyverna Therapeutics, Inc.
[{"type":"text","content":"The application was evaluated based on the positive clinical outcomes in patients treated in Germany under the named-patient program\nThe Regenerative Medicine Advanced Therapies designation allows Kyverna to leverage on more expedited meetings and more senior FDA leadership involvement throughout the development cycle for KYV-101\nEMERYVILLE, Calif., Aug. 12, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases, announced today the designation as Regenerative Medicine Advanced Therapy (RMAT) by the U.S. Food and Drug Administration (FDA) for its autologous, fully human CD19 chimeric antigen receptor (CAR) T-cell product candidate, KYV-101, to be used for the treatment of patients suffering from progressive myasthenia gravis. \n\n \n \n \n \n \n \n\n \n\"The RMAT designation underscores the attention and interest by the FDA in the development of potentially transforming therapies targeting a severe autoimmune disease such as myasthenia gravis,\" said Srikanth Muppidi, M.D., a neuromuscular disorder specialist at Stanford Medicine in Palo Alto, CA, and a principal investigator in the KYSA-6 trial. \"We are witnessing an era of profound changes in the approach to autoimmune conditions and ultimately, we hope this leads to a symptom-free state for patients.\"\n\"We are very happy with the constructive scientific rapport established between Kyverna and the FDA,\" said Peter Maag, Ph.D., chief executive officer at Kyverna. \"We believe the RMAT designation may ultimately add to our rigorous approach to KYV-101 development in the hope of benefitting the most deserving patients.\"\nAbout Myasthenia Gravis (MG)Myasthenia gravis is an autoimmune disorder associated with muscle weakness in tissues throughout the body, potentially manifesting in partial paralysis of eye movements, problems in chewing and swallowing, respiratory problems, speech difficulties and weakness in skeletal muscles. MG patients develop antibodies that lead to an immunological attack on critical signaling proteins at the junction between nerve and muscle cells, thereby inhibiting the ability of nerves to communicate properly with muscles. The symptoms of the disease can be transient and in the early stages of the dis...